A. Internal quality control
In all tests we include known positive and negative sera / CSF- controls. Most positive results are repeated both for confirmation and for a quantitative or semi-quantitative determination of the antibody titer. Also, already for the diagnosis of most diseases we apply two different methods (particularly in the case of a positive result) or we search for more than one biomarkers. Examples include testing for antibodies against AChR and MuSK (by standard RIA and new highly sensitive RIA, and with CBA when requested), against AQP4 (by CBA and RIA), against Titin (by ELISA and when deemed useful by RIA as well), against AQP1 (ELISA with whole AQP1 and with peptides corresponding to its extracellular and intracellular domains), against paraneoplastic antigen (by immunoblotting, tissue immunofluorescence and CBA), for multiple sclerosis (oligoclonal bands and quantitative IgG measurements albumin), for CJD (comparison of values for three proteins) and Alzheimer (comparison of values for four proteins). We make efforts the double check to be extended to almost all the tests we perform.
B. External quality control
We participate in several international quality control programs for as many of our tests are available (such as antibodies to the AChR, gangliosides, paraneoplastic antigens, oligoclonal bands in multiple sclerosis, myopathy antigens, NMDAR, CASPR1, LGI1, GAD, AQP4, Mup44 and the four CSF proteins involved in Alzheimer disease. For most of the other tests (for which we do not know the availability of organized external quality control), we confirm the reliability of our results by sending selected samples to collaborating international reference laboratories for confirmation. For some rare and very recent tests, we offer them in cooperation with certified reference laboratories abroad, until we adopt them in our laboratory. These include the detection of antibodies against ryanodine receptor, ganglionic AChR, GABAAR, mGluR1, mGluR5, Iglon5, VGCC type-N and dopamine receptors.
We operate under the international quality management standard ISO 9001: 2015.